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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000041851 |
Receipt No. | R000047707 |
Scientific Title | Effects of outpatient supervised exercise therapy on physical and renal function in patients with peripheral arterial disease of the lower extremities |
Date of disclosure of the study information | 2020/12/01 |
Last modified on | 2020/09/20 |
Basic information | ||
Public title | Effects of outpatient supervised exercise therapy on physical and renal function in patients with peripheral arterial disease of the lower extremities | |
Acronym | Effects of outpatient supervised exercise therapy on physical and renal function in patients with peripheral arterial disease of the lower extremities | |
Scientific Title | Effects of outpatient supervised exercise therapy on physical and renal function in patients with peripheral arterial disease of the lower extremities | |
Scientific Title:Acronym | Effects of outpatient supervised exercise therapy on physical and renal function in patients with peripheral arterial disease of the lower extremities | |
Region |
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Condition | |||
Condition | peripheral arterial disease of the lower extremities | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To determine the impact of a comprehensive outpatient cardiovascular disease rehabilitation program intervention after endovascular treatment for cases of peripheral arterial disease of the lower extremities on renal function, physical activity and gait function. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | physical function assessment : 6-Minute Walk Test, grip of hand, knee extension strength, pain-free walking distance, claudication onset time, maximum walking distance, peak walking time, Walking Impairment Questionnaire |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | No treatment |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | supervised exercise therapy | |
Interventions/Control_2 | conventional therapy | |
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | (1) Patients diagnosed with Fontain Class II peripheral artery disease of the lower extremities and admitted to Aomori Kyoritsu Hospital for endovascular treatment
(2) Patients who had been making regular outpatient visits at the same facility for at least 3 months prior to endovascular treatment (3) Patients who regularly visit the same facility as an outpatient for more than 3 months after discharge from the hospital. (4) Patients who have been provided with an explanation of the research and whose written consent has been obtained from them. |
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Key exclusion criteria | (1) Patients who are not able to walk independently
(2) Patients with critical limb ischemia (3) Dialysis patients (4) Patients with a diagnosis of dementia prior to discharge (5) Patients with untreated coronary artery disease (6) Patients with grade III or greater heart failure according to NYHA cardiac function classification (7) Patients with severe chronic obstructive pulmonary disease (8) Patients with poorly controlled diabetes (9) Patients with outflow tract stenosis due to aortic stenosis or hypertrophic cardiomyopathy or other diseases. (10) Patients with advanced atrioventricular block who have not had a pacemaker implanted. (11) Other patients who are deemed by the attending physician to be an undesirable subject for this study. |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Tohoku University Graduate School of Medicine | ||||||
Division name | Department of Internal Medicine & Rehabilitation Science Disability Science | ||||||
Zip code | 980-8574 | ||||||
Address | 1-1, Seiryo-cho, Aoba-ku Sendai | ||||||
TEL | 022-717-7351 | ||||||
kohzuki@med.tohoku.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Aomori Kyoritsu Hospital | ||||||
Division name | Internal Medicine | ||||||
Zip code | 030-0847 | ||||||
Address | 2-1-10 Higashi-Ohno, Aomori City | ||||||
TEL | 017-762-5500 | ||||||
Homepage URL | |||||||
takatakanaitou@med.tohoku.ac.jp |
Sponsor | |
Institute | Tohoku University |
Institute | |
Department |
Funding Source | |
Organization | Tohoku University |
Organization | |
Division | |
Category of Funding Organization | Government offices of other countries |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Tohoku University |
Address | 1-1, Seiryo-cho, Aoba-ku Sendai |
Tel | 022-717-7351 |
takatakanaitou@med.tohoku.ac.jp |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | あおもり協立病院(青森県) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047707 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |